1. Field of the Invention
The invention relates to the field of implantable fusion cages for use in the spinal column.
2. Description of the Prior Art
Fusion cages provide a space for inserting a bone graft between adjacent portions of bone. In time, the bone and bone graft grow together through or around the fusion cage to fuse the graft and the bone solidly together. One current use of fusion cages is to treat a variety of spinal disorders, including degenerative disc diseases, Grade I or II spondylolistheses, adult coliosis and other disorders of the lumbar spine. Spinal fusion cages (included in the general term, “fusion cages”) are inserted into the intervertebral disc space between two vertebrae for fusing them together. They distract (or expand) a collapsed disc space between two vertebrae to stabilize the vertebrae by preventing them from moving relative to each other.
The typical fusion cage is cylindrical, hollow, and threaded. Alternatively, some known fusion cages are unthreaded or made in tapered, elliptical, or rectangular shapes. Known fusion cages are constructed from a variety of materials including titanium alloys, porous tantalum, other metals, allograft bone, carbon fiber or ceramic material.
Fusion cages may be used to connect any adjacent portions of bone, however one primary use is in the lumbar spine. Fusion cages can also be used in the cervical or thoracic spine. Fusion cages can be inserted in the lumbar spine using an anterior, posterior, or lateral approach. Insertion is usually accomplished through a traditional open operation, but a laparoscopic or percutaneous insertion technique can also be used.
With any of the approaches, threaded fusion cages are inserted by first opening the disc space between two vertebrae of the lumbar spine using a wedge or other device on a first side of the vertebrae. Next, a tapered plug is hammered in to hold the disc space open in the case of a threaded, cylindrical cage insert. A threaded opening is then drilled and tapped on a second side opposite the first side of the vertebrae for producing the equivalent of a “split” threaded bore defined by the walls of the vertebrae above and below the bore. The threaded fusion cage is then threaded into the bore and the wedge is removed. The first side is then drilled and tapped before inserting a second threaded fusion cage. Typically, two threaded fusion cages are used at each invertebral disc level.
There are problems with all of the standard approaches. With a posterior approach, neural structures in the spinal canal and foramen need to be properly retracted before the plug is hammered or threaded into the disc space. Proper neural retraction is critical to the insertion process. If the retraction is not done properly, the procedure could cause neural injury, i.e., nerve damage and potential neurologic deficit. With either the anterior or lateral approach, blood vessels or other vital structures need to be retracted and protected to reduce or eliminate internal bleeding. Violation of the great vessels has a high mortality rate.
The general technique for inserting fusion cages is well known. Insertion techniques and additional details on the design of fusion cages is described in Internal Fixation and Fusion of the Lumbar Spine Using Threaded Interbody Cages, by Curtis A. Dickman, M. D., published in BNI Quarterly, Volume 13, No. 3, 1997, which is hereby incorporated by reference.
U.S. Pat. No. 5,782,832 to Larsen et al. (the “Larsen reference”) discloses an alternate type of spinal fusion implant. FIG. 1 of the Larsen reference shows an implant apparatus with two separable support components which are adapted for adjusting sliding movement relative to each other to selectively vary the overall width of the implant to accommodate vertebral columns of various sizes or to vary the supporting capacity of the implant during healing. Each of the support components include upper and lower plate portions that are operatively connected by respective linkage mechanisms. The linkage mechanisms allow relative movement of the upper and lower plate portions between an extended position and a collapsed position. The device disclosed in the Larsen reference has several problems. One problem is that, because the width of the implant is adjusted prior to insertion, a wide insertion slot is necessary despite the reduced profile presented by the collapsed implant. Another problem is that at least part of the linkage mechanism extends beyond the upper and lower plate portions, thus requiring more invasion into the body cavity to position the implant. Yet another problem is that the linkage mechanisms must be locked into the expanded position by conventional arrangements such as locking screws.
Brett, U.S. Pat. No. 6,126,689 (2000), illustrates an expandable and collapsible fusion cage, but it design is extremely complex and therefore expensive to manufacture and prone to failure in the field. Moreover, its complex linkages require special surgical skills in its deployment. Indeed, there is no reliable deployment mechanism. The Brett design requires large hinges which make it too large and therefore unsuitable for posterior insertion.
Within the past several years there has been a dramatic resurgence of interest in interbody lumbar spinal fusions without disruption of the vertebral body endplate. Part of this renewed direction has been due to waning popularity in both anterior and posterior approach cylindrical cage fusions. Interbody fusion seems to be more reliable than the classic posterior lateral fusion for several reasons. First, the two endplates of the vertebral bodies are close together, and under compression toward each other. Second, there is a large surface area to fuse. Visualization of the nerve roots is easily done from any posterior approach.
Shortcomings have included difficulty getting lumbar Lordosis, and placing a large graft through a small hole. Trans-facet lateral fusion has recently been introduced to overcome the small hole problem. In this procedure the entire facet is removed making a much wider access to the anterior disk space. To combat the instability problems this would cause the procedure is usually done only from one side, and almost always combined with pedicle screws.
A major reason to further develop good posterior approach fusions is that it avoids the anterior surgical approach with all of its inherent risks. Indeed, it is the low but real incidence of major complications associated with the anterior surgical approach which is largely responsible for the decreasing popularity of anteriorly placed cylindrical cages.
What is needed is a simple, reliable and stable design for an insertable fusion cage and some type of inserting tool by which the implantation can be made without requiring extraordinary surgical skills which arise from the design of the fusion cage.